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Sevoflurane, Propofol, Postoperative Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01437462
First received: September 19, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not proven in a large-scale study. The researchers aim to provide an investigation that has sufficient power to clarify the potential effect of anaesthetic method on postoperative need of opioids. Sevoflurane and propofol will be compared.


Condition Intervention Phase
Healthy Adults
Gynecological Disease
 Drug: Sevoflurane
Drug: Propofol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Postoperative Pain After Propofol Sevoflurane Anaesthesia: a Prospective, Randomized, Single-blinded Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Postoperative consumption of an opioid (oxycodone) [ Time Frame: 20 hours ] [ Designated as safety issue: No ]
    The consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump.


Secondary Outcome Measures:
  • NRS (numeral rating scale) of pain [ Time Frame: 20 hours ] [ Designated as safety issue: No ]
    NRS is evaluated frequently during the study period.


Enrollment: 168
Study Start Date: October 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sevoflurane
    Sevoflurane inhalation anesthesia, sufficient amount to maintain adequate general anesthesia for surgery
    Other Name: Baxter Sevofluran
    Drug: Propofol
    Propofol intravenous anesthesia, sufficient amount to maintain adequate anesthesia during surgery
    Other Name: Propofol Lipuro
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-69 years
  • Gender: female
  • ASA status 1-3
  • Laparoscopic hysterectomy

Exclusion Criteria:

  • Body Mass Index over 35
  • Diabetes mellitus
  • Liver disease
  • Allergies to pharmaceuticals used in the Study
  • Present use of opioids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437462

Locations
Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
  More Information

No publications provided

Responsible Party: Arvi Yli-Hankala, Professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01437462     History of Changes
Other Study ID Numbers: Satu_Pokkinen_01_2011
Study First Received: September 19, 2011
Last Updated: April 9, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Tampere University Hospital:
Pain, Postoperative
Anesthetics, intravenous
Anesthetics, inhalation
Otherwise healthy adults undergoing general anesthesia for gynecological disease.

Additional relevant MeSH terms:
Genital Diseases, Female
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Propofol
Sevoflurane
Anesthetics, Intravenous
 Anesthetics, Inhalation
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013